- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00291616
Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B
A Multicenter, Randomized, Controlled Trial of Combination Therapy for HBeAg Positive Chronic Hepatitis B: Comparing Thymosin Alpha 1 and Pegylated Interferon-alpha2a With Pegylated Interferon-alpha2a Alone.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B. It is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70% compared with that of single interferon therapy(20%). Until now, the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1. We hypothesized that thymosin alpha1 is an immune potentiator so, the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration.
In detail, we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone. Total treatment duration of both parallel groups will be 12 months, and the combination therapy will be lasted for the first 3 months followed by the next, ongoing pegylated interferon single therapy for 9 months.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Chongno-gu
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Seoul, Chongno-gu, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HBsAg positive and anti-HBs negative for more than 6 months
- HBeAg positive
- HBV DNA titer more than 100,000 IU/mL
- serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value
Exclusion Criteria:
- the history of antiviral therapy for chronic hepatitis B within the recent 6 months
- HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab +
- the sign of decompensated liver disease
- the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
- pregnant or lactating woman
- neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3
- serum creatinine more than 1.5 times upper normal limit value
- the sign of alcoholic or drug addiction within the recent 1 year
- the history of psychotic disorder especially like depression
- immunologically mediated disease
- the history of esophageal varix
- the history of severe heart disease or respiratory disease
- the history of severe epilepsy or current use of antiepileptic drug
- the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
- the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid
- the history of major organ transplantation
- the history of medically uncontrolled thyroid disease
- the history or sign of severe retinopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Pegylated Interferon-alpha2a
|
180 microgram s.c.
injection weekly
|
Active Comparator: 2
Thymosin alpha1 & Pegylated Interferon-alpha2a
|
Pegylated interferon 180 microgram s.c.
injection weekly Thymosin 1.6 mg s.c.
injection twice per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HBeAg seroconversion, HBV DNA titer<20,000 IU/mL
Time Frame: 48 week and 96 week
|
48 week and 96 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs
Time Frame: 48 week and 96 week
|
48 week and 96 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jung H Yoon, M.D., Seoul National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon-alpha
- Peginterferon alfa-2a
- Interferon alpha-2
- Thymalfasin
Other Study ID Numbers
- 12-05-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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